Actively Recruiting
Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression (COMBAT-SI)
Led by University of California, San Diego · Updated on 2025-11-05
76
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of bilateral accelerated theta burst stimulation (aTBS) on suicidal thoughts in people with treatment-resistant depression (TRD). This study compares bilateral aTBS to unilateral accelerated intermittent theta burst stimulation (aiTBS) over the left side of the brain. The goal is to confirm if bilateral aTBS can reduce suicidal ideation and to explore how it affects brain activity related to neuronal communication, called cortical inhibition. Participants will receive either bilateral aTBS or unilateral aiTBS treatments over five consecutive days. Each day involves 10 sessions lasting 10 minutes each, with 50-minute breaks between sessions. The bilateral group receives stimulation on both sides of the brain's dorsolateral prefrontal cortex (DLPFC), while the unilateral group receives stimulation on the left side with a sham (inactive) treatment on the right side. During the study, participants will be monitored for changes in suicidal thoughts using a suicide scale index over six months. Researchers will also measure brain activity related to cortical inhibition and track clinical outcomes related to suicidality. The study includes regular assessments and safety monitoring, with total participation lasting up to six months to observe treatment effects and brain changes.
CONDITIONS
Brief Title
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 to 70 years old
- Have a diagnosis of major depressive episode confirmed by a psychiatric interview with a depression score of 18 or higher
- Have ongoing suicidal thoughts with a score of 4 or higher on the Beck Scale for Suicide Ideation
- Pass safety screenings for transcranial magnetic stimulation and MRI
- Have failed to respond to or tolerate at least two antidepressant treatments based on treatment history
- Not have psychiatric illness due to a general medical condition
- Be a voluntary outpatient capable of consenting to treatment and able to follow the treatment schedule
You will not qualify if you...
- Have a substance use disorder diagnosis within the last 3 months
- Have a lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- Have certain primary psychiatric disorders like obsessive compulsive disorder, post-traumatic stress disorder, anxiety disorders, or dysthymia if more impairing than depression
- Have a primary personality disorder causing more impairment than depression
- Have suicidal thoughts requiring emergency involuntary hospitalization
- Currently pregnant or breastfeeding, or childbearing without adequate birth control
- Have significant sensory impairments preventing cooperation with interviews
- Not capable of consenting to treatment or unsuitable for outpatient care
- Have major unstable medical illnesses, pacemakers, implanted pumps, neurological disorders, intracranial implants, or metal objects near the head that cannot be safely removed
- Take more than 2 mg daily of lorazepam (or equivalent) or any anticonvulsant medication that could limit treatment efficacy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days
Participants receive accelerated theta burst stimulation treatments targeting the brain's frontal lobes for suicidal ideation in treatment-resistant depression.
Daily visits for 5 consecutive days
Duration - Up to 6 months
Participants are monitored to assess suicidal ideation and neurophysiological changes after treatment.
Periodic visits during 6 months follow-up
Trial Site Locations
Total: 1 location
1
UCSD Interventional Psychiatry
San Diego, California, United States, 92127
Actively Recruiting
Research Team
I
Interventional Psychiatry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here